FDAnews Device Daily Bulletin
Feb. 9, 2005 | Vol. 2 No. 28
The FDA has released highlights of its fiscal 2006 budget request to Congress totaling $1.9 billion, including $1.5 billion in budget authority and $382 million in congressionally authorized industry user fees -- 50 percent higher than the appropriations in fiscal 2001 and a 4.5 percent increase over the fiscal 2005 level.
The FDA warned consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the internet by Globus Media, Montreal, Canada.
Align Technology, the inventor of Invisalign -- a proprietary method of straightening teeth without wires and brackets has announced the acquisition of General Orthodontic (GO) as part of the company's ongoing commitment to providing clinical support for Invisalign doctors.
B. Braun announced the availability of the LidoSite Topical System, a method to help reduce needlestick pain associated with procedures such as intravenous cannulation, venipuncture or laser ablation of superficial skin lesions for patients ages 5 and up.
The University of Texas M.D. Anderson Cancer Center
has granted an exclusive license to Quest Diagnostics for the use of five proprietary
blood testing methods that have the potential to eliminate the need for painful
and expensive bone marrow and other tissue extractions.
Having survived the Utah Senate, a bill holding reprocessors of "single-use" medical devices completely liable for the recycled products' safety could come to a final House vote within a week.
Biomerica has announced it is launching a new diabetes diagnostic blood test to measure levels of C-peptide in blood. C-peptide levels in blood are about five to six times greater than insulin levels and are more stable.
Chindex International, an independent American distributor of Western healthcare products and services in China, has announced that its German subsidiary, Chindex China-Export, has been awarded a contract to supply medical equipment to hospitals in two Chinese provinces under a financing arrangement sponsored by the German government and funded by KfW Development Bank.
Cambridge Heart has announced that the "Risk Estimation Following Infarction -- Noninvasive Evaluation Study (REFINE) has completed its enrollment of 350 patients.
Visiomed has announced the appointment of William Dolphin as CEO, replacing the retiring Saliba Sassine who has accepted a non executive board position and will remain a major shareholder.
International Sports and Media Group (ISME) has announced its joint marketing agreement with BioTech Medics (BTMD).
EBI has introduced a new line of Osteobiologics: Pro Osteon Osteobiologics. In addition to Traditional Allograft, Resorbable Granules and Blocks, Synthetic Bone Graft Substitutes and DBM Putty, the new Pro Osteon line now includes: DBM Paste, Bone Marrow Aspirate and Concentrators, Bone Void Fillers and Machined Graft Substitutes.
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